Slip-Ease™ Cushions
GUDID 50732224003042
X-Ray cushions
CROSSTEX INTERNATIONAL, INC.
Dental x-ray film holder, single-use| Primary Device ID | 50732224003042 |
| NIH Device Record Key | 9af560fc-b16d-4385-ace7-047a931f9316 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Slip-Ease™ Cushions |
| Version Model Number | BWSEL |
| Company DUNS | 057728685 |
| Company Name | CROSSTEX INTERNATIONAL, INC. |
| Device Count | 100 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00732224003047 [Unit of Use] |
| GS1 | 10732224003044 [Primary] |
| GS1 | 50732224003042 [Package] Contains: 10732224003044 Package: [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K852170
FDA Product Code
| EGZ | Holder, film, x-ray |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-07 |
| Device Publish Date | 2022-09-29 |
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| 20815878025321 - Burkhart Non-Woven Sponges | 2024-04-17 |
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| 20815878027592 - Burkhart Cotton Rolls | 2024-04-17 |
Trademark Results [Slip-Ease]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SLIP-EASE 85553152 4217560 Live/Registered |
CROSSTEX INTERNATIONAL, INC. 2012-02-27 |
 SLIP-EASE 81043467 1043467 Dead/Cancelled |
Richton International Corporation 0000-00-00 |
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